Identity
- Device Name
- Plates Activ Ankle, Xpert Ankle EUDAMED
- Model / Reference
- RTGLS2-ST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700569624811 EUDAMED
- Basic UDI-DI
- 3700569600068U EUDAMED
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthopaedic fixation plate, non-bioabsorbable
Plates Activ Ankle, Xpert Ankle by Newclip Technics SAS — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3700569600068U | Class IIb | Active |
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Manufacturer
- Manufacturer
- Newclip Technics SAS
- EUDAMED SRN
- FR-MF-000011809
Sources (1)
- EUDAMED d558fc4a-3271-4f83-b7eb-6b697b50033a 61 fields · synced Aug 4, 2026